Cancer Genome Study Using Samples From Patients With Stage I or Stage II Non-Small Cell Lung Cancer Treated on Clinical Trial ACOSOG-Z0030

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Lung Cancer

Treatments: Genetic: polymorphism analysis; Genetic: RNA analysis; Genetic: microarray analysis; Genetic: DNA analysis; Genetic: mutation analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00899535

ACOSOG-Z4082

CDR0000617514 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at the cancer genome using tumor samples from patients with stage I or stage II non-small cell lung cancer treated on clinical trial ACOSOG-Z0030.

Full description

OBJECTIVES:

• To investigate the clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens from patients with stage I or II, N0 or N1 (less than hilar) non-small cell lung cancer.

OUTLINE: This is a multicenter study.

Biological specimens are collected from participating clinical sites and analyzed by transcription profiling of RNA and microRNA; detection of DNA copy number changes and chromosomal rearrangements; epigenetic modifications analyses; and sequencing of genomic segments, genes, and regulatory regions to assess sequence variation. Clinical information associated with each specimen donor is also collected.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of non-small cell carcinoma

  • Primary, untreated disease

  • Stage I or II (T1 or T2, N0 or non-hilar N1, M0) disease

  • Any of the following histologies allowed:

    • Squamous cell carcinoma
    • Adenocarcinoma (< 10%)
    • Large cell carcinoma (high-grade)

• Available tumor tissue samples collected on clinical trial ACOSOG-Z0030 and meeting the following criteria:

  • Snap-frozen and stored at a temperature of -80°C or lower
  • Specimens may come from any site within the lung or one that is involved by direct regional extension of tumor from the originating site in the lung

• No regional lymph node or distant metastases

• No recurrent or persistent disease after prior neoadjuvant or adjuvant treatment for lung cancer

• Must have matching frozen samples of normal tissue and blood

Trial design

70 participants in 1 patient group

Group 1

Description:

This research study is looking at the cancer genome using tumor samples from patients with stage I or stage II non-small cell lung cancer treated on clinical trial ACOSOG-Z0030. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

Treatment:

Genetic: microarray analysis

Genetic: DNA analysis

Genetic: polymorphism analysis

Genetic: mutation analysis

Genetic: RNA analysis